Research Data Coordinator

Job Summary:

Responsibilities:

Research Coordinator for a Dynamic and Expanding Outpatient Oncology Research Department

The position entails managing research activities within a bustling outpatient oncology research department.

The role necessitates on-site availability for 8-hour shifts, Monday through Friday.

Responsible for coordinating clinical trials, including study initiation, collection of clinical data, and management of data entry

Using OnCore, Excel, and Word, creates study tools such as eligibility checklists, medication diaries, calendars, and flow sheets, as required.

Collaborates with the Research Nurse Clinician and/or physician to review patient charts and medical history, confirming protocol eligibility and obtaining necessary source documents

Ensures IRB-approved informed consent is obtained, signed, placed in the medical record, and provided to the patient under the direction of the RNC and/or physician

Registers consented research patients with study sponsors and input data into the OnCore clinical trials' database managed by the Cancer Institute of New Jersey and RWJUH Somerset

Scheduling patient appointments, coordinating clinical assessments and patient care for study participants, liaising with ancillary departments within the Cancer Institute per protocol requirements

Maintains comprehensive research records for all patients enrolled in Cancer Institute of New Jersey and RWJUH Somerset clinical trials,

Assists in grading adverse events and completes Serious/Unexpected Adverse Event forms as required by study sponsors and regulatory guidelines

Enters data into auditable databases or electronic data capture systems, ensuring accuracy and addressing queries from monitors

Provides regular reports to Disease Specific Group members and Principal Investigator using OnCore

Acts as a liaison with study sponsors, scheduling monitoring visits and conference calls, and providing timely responses to queries

Ensures adherence to treatment plans and Good Clinical Practice guidelines by Cancer Institute and RWJUH Somerset personnel, including investigators

Participates in ongoing quality assurance activities and communicates effectively with staff and outside agencies to promote teamwork

Collaborates with Biorepository Services to meet study-specific deadlines for sample submission and obtain specialized reports as needed

Adheres to policies and procedures set forth by RBHS, Cancer Institute of New Jersey, RWJUH Somerset, FDA, and regulatory bodies

Maintains trial regulatory binders and ensures compliance with Institutional, State, and Federal regulations throughout the research project

Ensures research protocols are approved by the Institutional Review Board and followed as written

Qualifications:

Bachelor s Degree in a related field

Clinical Research experience preferred

Strong interpersonal and communication skills are required.

Must be self-motivated and able to multitask on a variety of projects

RWJBarnabas Health is an Equal Opportunity Employer